Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices 87787 

contentions concerning his debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(3)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Jeremy 

Walenty has been convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 

of any drug or controlled substance. 

FDA finds that the offense should be 

accorded a debarment period of 5 years 

as provided by section 306(c)(2)(A)(iii) 

of the FD&C Act. 

As a result of the foregoing finding, 

Mr. Walenty is debarred for a period of 

5 years from importing or offering for 

import any drug into the United States, 

effective (see DATES). Pursuant to section 

301(cc) of the FD&C Act (21 U.S.C. 

331(cc)), the importing or offering for 

import into the United States of any 

drug by, with the assistance of, or at the 

direction of Mr. Walenty is a prohibited 

act. 

Dated: December 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27855 Filed 12–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5431] 

Hospira, Inc., et al.; Withdrawal of 

Approval of Eight Abbreviated New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

withdrawing approval of eight 

abbreviated new drug applications 

(ANDAs) from multiple applicants. The 

applicants notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

January 18, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived the 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 063081 ........ Tobramycin Sulfate, Injectable, Equivalent to (EQ) 1.2 milligrams (mg) base/milliliters (mL), EQ 1.6 mg base/mL, EQ 

80 mg base/100 mL.

Hospira, Inc., 275 North Field Dr., Building H1–3S, Lake 

Forest, IL 60045. 

ANDA 063112 ........ Tobramycin Sulfate, Injection, EQ 10 mg base/mL ............... Do. 

ANDA 078907 ........ Fentanyl Citrate, Troche/Lozenges, EQ 0.2 mg base, EQ 

0.4 mg base, EQ 0.6 mg base, EQ 0.8 mg base, EQ 1.2 

mg base, EQ 1.6 mg base.

SpecGx LLC, 385 Marshall Ave., Webster Groves, MO 

63119. 

ANDA 080629 ........ Promethazine Hydrochloride (HCl), Injectable, 50 mg/mL .... Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Parkway, Building A, Parsippany, NJ 07054. 

ANDA 091170 ........ Zoledronic Acid, Injectable, EQ 4 mg base/5 mL .................. Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 

201, Berlin, CT 06037. 

ANDA 201846 ........ Azelastine HCl, Metered Spray, 0.2055 mg/spray ................. Apotex Corp, U.S. Agent for Apotex Inc., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326. 

ANDA 207698 ........ Nevirapine Extended-Release Tablets, 400 mg .................... Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo 

Pharma Limited, 279 Princeton-Hightstown Rd., East 

Windsor, NJ 08520. 

ANDA 208616 ........ Nevirapine Extended-Release Tablets, 100 mg .................... Do. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of January 18, 

2024. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

listed in the table without an approved 

new drug application or ANDA violates 

sections 505(a) and 301(d) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(a) and 331(d)). Drug products that 

are listed in the table that are in 

inventory on January 18, 2024 may 

continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: December 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27853 Filed 12–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0026] 

Apothecon, et al.; Withdrawal of 

Approval of 103 New Drug 

Applications and 35 Abbreviated New 

Drug Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on February 11, 2009. The 


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